The present invention relates generally to surgical staples, staplers, anastomosis devices, and methods for their applications.
The surgical uniting of tissues or tendons with sutures is a demanding skill, requiring dexterous ease in performance. Post operation healing is best facilitated by as short as possible operation time, minimal blood loss, and least tissue manipulation and trauma. Yet, often, sutures are to be placed in difficult to reach places, and their specific location, size, and tautness must be carefully controlled and delicately manipulated. In addition, fatigue and loss of patience may have an effect on the quality of the sutures. Furthermore, there is great variance in the quality of sutures between highly skilled and lesser skilled surgeons.
Generally, fine threads are used to surgically close a wound or join tissues. Alternatively, surgical staples, for example, Auto Suture of U.S. Surgical, 150 Glover Avenue, Norwalk, Conn. 06856, may be employed.
FIGS. 1A-1D schematically illustrate skin closure by an Auto-Suture instrument 10 and shape-memory-alloy staples 12, which form figure-eight staples after insertion. For operation, the surgeon must maintain first and second fascia edges 14 and 16 taut, abut against each other, and hold instrument 10 substantially at a right angle to the fascia surface.
There are several disadvantages to the Auto-Suture system:
maintaining fascia edges 14 and 16 taut and abut against each other requires at least two additional tools, such as tools 18A, 18B and 18C of FIG. 1A. It would be advantageous, if the surgeon could grip first fascia edge 14, as if by needle, and bring it to second fascia edge 16, so that the overall number of tools be reduced;
Staple ejection by Auto Suture device 10 may be crushing to the tissue, possibly leading to local necrosis;
additionally, the figure eight that is formed by staples 12 may further crush the tissue, as seen in FIG. 1D, and may interfere with blood and nutrient flow, possibly leading to local necrosis; and
when the Auto-Suture device is held at 90° to the fascia, as recommended, the surgeon's elbow makes an angle α of about 120° with the his arm; the hand is thus near the end of its rotational travel in that orientation, and its maneuverability is limited.
While the present example is based on skin staples, which are later removed, the principles of operation are similar for internal Auto-Sutures.
Additionally, FIGS. 1E-1F schematically compare internal body seams made by Auto-Suture staples 12 and those made by hand, with a surgical thread, for example, for transverse anastomosis for a stomach 13. As seen in FIG. 1E, sutures 12, made by Auto-Suture staples and forming seams 11, are parallel with the surgical cut. In contrast, as seen in FIG. 1F, sutures 15, made by hand, using a surgical thread and forming seams 17, are generally perpendicular to the cut. The situation of FIG. 1F of sutures that are perpendicular to the cut is preferred, since in FIG. 1E, the sutures may block blood flow across to tissue on the far side f the seam.
U.S. Pat. No. 6,113,611 to Allen et al., “Surgical fastener and delivery system,” whose disclosure is incorporated herein by reference, describes a surgical fastener preferably made from a shape memory alloy, which can access internal tissue or other synthetic material through a small surgical access port or incision. After the fastener is deployed through layers of tissue, it assumes a shape of a plurality of closes, that automatically applies to the layers of tissue an appropriate haemostatic compression which is relatively independent of tissue thickness. A delivery instrument for deploying the fastener is also provided. In essence, the surgical fastener, according to U.S. Pat. No. 6,113,611, is a staple-like device, and the delivery instrument for deploying the fastener operates as a stapler, having a rigid bottom plate. The staple pierces the tissue and then encounters the rigid bottom plate, which forces it to close over the tissue.
Yet, because it is designed to apply a haemostatic compression to the layers of tissue, the surgical fastener of U.S. Pat. No. 6,113,611 may cause tissue trauma, by interfering with blood and nutrient flow. In consequence, local necrosis can occur. Furthermore, in some embodiments, one or two sharp leading edges may be exposed, and may cause internal injury.
U.S. Pat. No. 6,517,584, to Lecalve, “Flexible prosthesis in particular for curing hernias by colioscopy,” whose disclosure is incorporated herein by reference, describes a flexible prosthesis, in particular for curing hernias by colioscopy. The prosthesis includes at least one anchor device, made of a shape memory material, designed to be deformed merely under temperature control from a storage position into a fixing position, in which the anchor device interferes with the surrounding tissue. The device pierces the tissue at two ends, and forms a loop.
U.S. Pat. No. 5,002,563, to Pyka, et al., “Sutures utilizing shape memory alloys,” whose disclosure is incorporated herein by reference, describes a suture and a method for suturing a wound in the tissue. In the preferred embodiment, Pyka, et al. use a needle, of a greater stiffness then the suture, to pierce the tissue. The needle is then cut off, and the suture may be tied, for example, by hand. In consequence, it requires considerable handling, and does not offer a solution to applying sutures in hard-to-reach places, taughtness control, fatigue, and less-skilled surgeons. Furthermore, it does not teach the simultaneous application of multiple sutures. Additionally, the preferred embodiment utilizes a needle, which is generally coarser than the suture, and in consequence, may be traumatic to the tissue.
Endoanchor™, of Johnson and Johnson Co. is a shape memory anchor having a delivery device. However, its application is limited to fixing a mesh or a patch to the tissue.
A shortcoming of the entire available prior art systems are that in order to change the direction of closing, one must change the orientation of application device.
There is thus a widely recognized need for, and it would be highly advantageous to have staplers, staplers, anastomosis devices, and methods for their applications devoid of the above limitations.